Description

Course Information

This course offers foundational guidance and practical support tailored for individuals operating within Good Manufacturing Practice (GMP) frameworks.

Explore the fundamental prerequisites of a pharmaceutical quality system (PQS) and delve into the application of quality risk management (QRM) principles, aligning with current regulations and guidance. Gain insights into pivotal aspects such as requirements, roles, and responsibilities, encompassing change control, document management, and key documentation essential for effective implementation of GMP with a focus on regulatory inspections and common findings.

Is this course for you?

Ideal for professionals engaged in GMP across various sectors, including:

Research and Development (R&D)

Contract Manufacturing Organisations

Manufacturing Units

Quality Control (QC) Laboratories

Auditing Roles.

What will you learn?

Event objectives - by the end of the course, delegates shall:

Have an awareness of the basic requirements of GMP

Be aware of UK and EU GMP Rules and Guidance and relevant publications

Understand the roles and responsibilities associated with GMP

Be able to contribute to and maintain quality documentation

Have a basic understanding of product lifecycle and manufacturing

Understand the requirements of GMP in the QC laboratory context

Have a basic understanding of risk management and mitigation principles

Understand the need for quality systems and quality assurance activities

Be aware of common regulatory findings.

Learning outcomes: delegates will be able to:

Implement their role within GMP with confidence and knowledge of the principle requirements

Contribute effectively to the GMP quality system and their organisation’s compliance

Comprehend where their organisation’s activities sit within the larger GMP arena

Know where to seek further information within the published rules and guidance, UK Legislation, European Commission Directives, ICH Guidance and other relevant publications, as well as via the internet.

Tutors

Tutors will be comprised of (click the photos for biographies):

Louise Handy

Director, Handy Consulting Ltd

Programme

Please note timings may be subject to alteration.

Day 1